mHealth Intervention for Older Adults

NCT03398590 | Completed

• 1 other identifier: 17.192.01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to test the feasibility and acceptability of a self-regulation theory-based mHealth behavior intervention for overweight or obese older adults with T2DM.

Conditions

Type2 Diabetes; Obesity

Keywords

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Actual Use of Technology will be defined as binary (use vs. nonuse) for each day based on data-stamp information. Then we will calculate percent days of use over time.

  From baseline to the end of study (up to 3 months)

Secondary Outcomes (3)

• Percent weight change

  From baseline to the end of study (up to 3 months)

• Steps

  From baseline to the end of study (up to 3 months)

• Calorie intake

  Mean steps over 3 months

Study Arms (1)

mHealth Intervention for Older Adults

EXPERIMENTAL

Pilot study to test the feasibility and acceptability of a self-regulation theory-based mHealth behavior intervention for overweight or obese older adults with T2DM. This is a one Group Pretest-Posttest Designed study. Ten participants will be recruited from Joslin Diabetes Center, Boston, MA. They will receive a 2-month, self-regulation theory-based weight loss intervention (five 60-minute, biweekly group sessions) and will be provided with a technology toolkit for self-monitoring including an (1) iPhone Plus, (2) the Lose It! app for self-monitoring of dietary intake, (3) Fitbit for self-monitoring of physical activity, (4) Bluetooth-enabled scale for daily weight, and (5) Bluetooth-enabled blood glucose monitor for testing blood glucose levels.

Behavioral: self-regulation theory-based mHealth behavior intervention

Interventions

self-regulation theory-based mHealth behavior intervention BEHAVIORAL

Participants will receive a self-regulation theory-based mHealth behavior intervention (5 biweekly group sessions, 60 minutes /session). An experienced Certified Diabetes Educator from the Joslin Diabetes Center and PI (Dr. Zheng) who has been trained using self-regulation for weight loss will co-facilitate group sessions. The intervention combines diet modification and increased physical activity with a weekly weight loss goal as well as focuses on improving participants' three typical self-regulation strategies - self-monitoring, self-evaluation and self-reinforcement. Intervention duration will last 2 months with subsequent 1-month follow.

mHealth Intervention for Older Adults

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \>=65 years of age;
• BMI between 27-40kg/m2
• Availability of wireless Internet service at home;
• Stable body weight during the previous year (i.e., ±10 pounds) ;
• Not being enrolled in another weight loss program in the past six months;
• Diagnosed with type 2 diabetes for at least 2 years;
• Prescribed insulin or oral medications for at least 1 year;
• No changes in medications for at least 6 months before enrolling in the study;
• Use the LoseIt! app on their computer or smartphone for the 5-day practice period;
• Able to read, write and speak English.

You may not qualify if:

• Planning frequent travel, vacations or relocation in next 3 months;
• Current use of weight loss medication;
• Have a history of bariatric surgery;
• Have participated in diabetes education in the previous 12 months;
• Are unable to walk 2 blocks, or had an amputation of a lower limb, severe arthritis or other medical condition that prevents walking for exercise;
• Have severe complications of diabetes, including renal disease (albumin/creatinine \>300 μg /mg), severe peripheral diabetic neuropathy, severe peripheral vascular disease, symptomatic autonomic neuropathy, history of myocardial infarction, congestive heart failure, or other severe cardiac disease or severe hypertension (systolic blood pressure greater than 160/90 mmHg);
• Have a diagnosis of a serious mental illness, e.g. schizophrenia, bipolar disorder, substance abuse, and/or eating disorders;
• Have severe visual, hearing or cognitive impairments (e.g., dementia, intellectual disability);
• Unable or unwilling to use the mHealth technology equipment (toolkit) for data collection;
• Do not speak, read and write English.

Sponsors & Collaborators

• Boston College: lead
• Joslin Diabetes Center: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yaguang Zheng, PhD

  Boston College Connell School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: January 12, 2018
• Study Start: April 12, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

US (1)